FDA Issues Yet Another Warning Over Celexa Use
The FDA has issued a drug safety alert for the antidepressant Celexa (citalopram, also available as a generic), reducing the recommended maximum daily dosage to 40 mg/day. The alert is due to a new study which found the previously recommended higher dose of 60-mg/day can cause abnormal changes in the electrical activity of the heart. […]
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FDA Adds Risk of Ovarian Failure to Avaistin’s Warning Label
Treatment with the cancer drug Avastin may affect fertility in some women, the Food and Drug Administration (FDA) said Tuesday. The agency said a new warning about the risk of “ovarian failure” was added to the drug’s label. The FDA further advised doctors to counsel women of child-bearing age about the possibility that taking Avastin […]
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So Many Jobs Are Gone, Pharma Layoffs Dwindle
As you know, this has not been a good decade for pharma employment. The combination of patent expirations, thinning pipelines and fewer new drug approvals has prompted every drugmaker – big and small – to toss tens of thousands of people overboard. But so many jobs have been eliminated that the layoff pace is finally […]
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J&J To Pay $48M To Man Hurt By Motrin
A Los Angeles jury has ordered Johnson & Johnson and its McNeil Consumer Healthcare unit to pay $48.2 million to a man who developed a severe skin disorder and blood blisters in his mouth after taking the Motrin over-the-counter pain reliever. In reaching its decision, the jury found that the Motrin labeling was inadequate and […]
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Tax Holidays, Job Losses And Pharma
As talk on Capitol Hill turns toward a possible ‘tax holiday’ for large corporations with huge sums of money parked overseas, a new report points out that many of the companies that benefit from that congressional largesse may have gained a big subsidy, but also eliminated thousands of jobs. And high on that list are […]
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Bayer puts sharper focus on Japan
Bayer says that it will expand its business in Japan, “despite the difficult conditions following the earthquake and tsunami disaster” and expects solid sales growth in the coming years. Chairman Marijn Dekkers, speaking at a news conference held in Tokyo to mark the centenary of Bayer’s Japanese subsidiary, said the country “has been and continues […]
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Why Contract Research Organizations Are Hot
With more drugmakers outsourcing more trials to contract research organizations, few should be surprised that the CRO sector is generating investor interest. The attention-grabbing deal announced yesterday in which two private equity firms – Carlyle Group and Hellman & Friedman – agreed to pay $3.9 billion in cash to buy Pharmaceutical Product Development is no […]
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J&J Wins Shareholder Suit Over Board Misconduct
A federal court judge has tossed a so-called derivate lawsuit in which a group of Johnson & Johnson shareholders charged that the health care giant’s board of directors breached their fiduciary duty, despite a series of red flags in the form of FDA warning letters; government subpoenas; a criminal plea to kickback charges; whistleblower lawsuits; […]
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FDA agrees to deal that speeds reviews
The Food and Drug Administration and the biopharma industry have agreed in principle on a revamp of the Prescription Drug User Fee Act, by which drug firms provide nearly two-thirds of what the agency spends on drug reviews. The agency, which is still wrangling with the generic drug and device industries over user fee agreements, […]
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Cephalon Gets U.S. Justice Department Subpoena for Top-Sellers
Cephalon Inc. (CEPH) received a subpoena from the U.S. Justice Department asking for information about the marketing of Nuvigil and Provigil, the company’s best- selling medicines to promote wakefulness. Cephalon, based in Frazer, Pennsylvania, said it will fully cooperate and is responding to the request, which was disclosed in a filing with the U.S. Securities […]
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